生物制品gmp檢查指南(完整版)
【正文】 LINE FOR BIOPRODUCT由國(guó)家食品藥品監(jiān)督管理局頒發(fā)ISSUED BY SFDA OF CHINA1. 機(jī)構(gòu)與人員 COMPANY ORGANIZATION AND PERSONNEL224。Whether the storage about the production or nonproduction cell bank or seed bank, strong or weak strain, inactive or active strain, before or after detoxicant, dead or living strain, human blood product, defendant product etc. are strictly separated.224。Whether the air system for various bioproducts related to high risk pathogenic factors which are in pliance with the special requirement. 224。The equipment must be specified in the production of sporeformer. Is the production centralized when processing one preparation? When manufacturing different varieties of spore products with one set of equipment in turn, is that only one product to be prepared in the established period. 224。Whether only authorized personnel are permitted to enter the area where storing the seed lot and cell bank and whether all these materials are stored in the specified warehouse pursuant to the specified condition. 224。All kinds of inactive vaccines (including rebinant DNA products), toxoid and cell extract which can be filling and lyophilized in the same equipment alternately with others sterile products after inactivation or disinfecting process. But after the distribution of one product, the equipment must be effectively cleaned and disinfected right away and verify the effectiveness of cleaning and disinfecting periodically. 224。 2221：用于加工處理活生物體的生物制品生產(chǎn)操作區(qū)和設(shè)備是否便于清潔和去除污染，能耐受熏蒸消毒。 3103：生物制品生產(chǎn)使用的管道系統(tǒng)、閥門(mén)和通氣過(guò)濾器是否便于清潔和滅菌，封閉性容器（如發(fā)酵罐）是否用蒸汽滅菌。 ＊4402：菌毒種是否按規(guī)定驗(yàn)收、儲(chǔ)存、保管、使用、銷毀。 4406：種子批系統(tǒng)是否有菌毒種原始來(lái)源、菌毒種特征鑒定、傳代譜系、菌毒種是否為單一純微生物、生產(chǎn)和培育特征、最適保存條件等完整資料。After the process of high risk pathogen such as: ma bacillus, Pasteurella pestis (plague bacillus), HIV, and hepatitis B virus etc, the suspect contaminant must be sterilized in place, and to be removed out of working area after individual sterilization. 224。Whether the personnel with infectious disease, skin disease, or with body lesion etc. that has potential negative influence to the quality of bioproducts who enter the production area or participate in the process or inspection. 6. 驗(yàn)證 VALIDATION7. 文件 DOCUMENT8. 生產(chǎn)管理 PRODUCTION MANAGEMENT224。生產(chǎn)企業(yè)是否根據(jù)國(guó)家標(biāo)準(zhǔn)品制備其工作品標(biāo)準(zhǔn)。 7602：生物制品生產(chǎn)用物料是否對(duì)供應(yīng)商進(jìn)行評(píng)估并與之簽訂較固定合同，以確保其物料的質(zhì)量和穩(wěn)定性。Whether the bioproducts to be manufactured strictly pursuant to the “China Bioproduct Manufacture Procedure” or the procedure approved by SFDA. 224。In the manufacture day of bioproduct, whether the personnel to be decontaminated according to the established provision and only after this they are permitted to enter others ordinary working areas from the working area of microorganism or animal related materi
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